Kinect-based Upper Limb Rehabilitation System in Stroke Patients
Primary Purpose
Stroke, Hemiplegia, Virtual Rehabilitation
Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Kinect-based rehabilitation plus occupational therapy
sham virtual rehabilitation education plus occupational therapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- Age from 20 to 80 years
- Stroke within prior 3 months
- Unilateral upper extremity weakness
Exclusion Criteria:
- Uncontrolled medical conditions
- Who cannot obey the simple command
- Who has the hemispatial neglect, visual impairment, apraxia
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Kinect-based Rehabilitation
Self-exercises education
Arm Description
Outcomes
Primary Outcome Measures
Change from Baseline in Fugl-Meyer Assessment Scale for upper extremity at 2 weeks
Secondary Outcome Measures
Brunnstrom stage
This is composed of 6 stages. Higher score means better function. The description for each stage as follows.
Flaccidity: no voluntary movement.
Synergies or minimal voluntary movement.
Synergies performed voluntary (spasticity gratest).
Some deviation from synergy.
Independent or isolated movement.
Individual joint movement nearly normal with minimal spasticity.
Modified Barthel Index
Box and Block Test
Individuals are seated at a table, facing a rectangular box that is divided into two square compartments of equal dimension by means of a partition.
One hundred and fifty, 2.5 cm, colored, wooden cubes or blocks are placed in one compartment or the other.
The individual is instructed to move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds.
The BBT is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period.
Number of movement counts during rehabilitation using accelerometer data
Full Information
NCT ID
NCT02066116
First Posted
February 13, 2014
Last Updated
November 1, 2017
Sponsor
Seoul National University Bundang Hospital
Collaborators
Microsoft Research, The Ministry of Science, ICT and Future Planning, Korea
1. Study Identification
Unique Protocol Identification Number
NCT02066116
Brief Title
Kinect-based Upper Limb Rehabilitation System in Stroke Patients
Official Title
Effect of Kinect-based Upper Limb Rehabilitation System in Patients With Stroke: A Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
enrollment is difficult and pilot nature of this study
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
Microsoft Research, The Ministry of Science, ICT and Future Planning, Korea
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators have developed the kinect-based upper extremity rehabilitation program and designed this protocol to prove the efficacy of this program.
In brief, subacute stroke patients allocated to intervention group will receive the kinect based-rehabilitation program plus conventional occupational therapy and patients allocated to control group will receive the sham virtual rehabilitation plus conventional occupational therapy, for 10 days.
20 patients with subacute stroke will be allocated into each group and after completing the 10 days intervention, they will be assessed by using objective assessment tools for upper extremity function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiplegia, Virtual Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kinect-based Rehabilitation
Arm Type
Experimental
Arm Title
Self-exercises education
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Kinect-based rehabilitation plus occupational therapy
Intervention Description
The developed kinect-based rehabilitation system will be used for 30min/session. Conventional 30min occupational therapy also will be applied for the patient enrolled.
Intervention Type
Other
Intervention Name(s)
sham virtual rehabilitation education plus occupational therapy
Intervention Description
For the sham virtual rehabilitation, computer-based cognitive rehabilitation program will be used. Patients will be encouraged to use their affected arm to push the button but the motion will be minimal and not related to the concept of upper extremity rehabilitation.
Primary Outcome Measure Information:
Title
Change from Baseline in Fugl-Meyer Assessment Scale for upper extremity at 2 weeks
Time Frame
Baseline, 2 weeks after the baseline
Secondary Outcome Measure Information:
Title
Brunnstrom stage
Description
This is composed of 6 stages. Higher score means better function. The description for each stage as follows.
Flaccidity: no voluntary movement.
Synergies or minimal voluntary movement.
Synergies performed voluntary (spasticity gratest).
Some deviation from synergy.
Independent or isolated movement.
Individual joint movement nearly normal with minimal spasticity.
Time Frame
Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline
Title
Modified Barthel Index
Time Frame
Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline
Title
Box and Block Test
Description
Individuals are seated at a table, facing a rectangular box that is divided into two square compartments of equal dimension by means of a partition.
One hundred and fifty, 2.5 cm, colored, wooden cubes or blocks are placed in one compartment or the other.
The individual is instructed to move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds.
The BBT is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period.
Time Frame
Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline
Title
Number of movement counts during rehabilitation using accelerometer data
Time Frame
Baseline, 2 weeks after the baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age from 20 to 80 years
Stroke within prior 3 months
Unilateral upper extremity weakness
Exclusion Criteria:
Uncontrolled medical conditions
Who cannot obey the simple command
Who has the hemispatial neglect, visual impairment, apraxia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nam-Jong Paik, MD, PhD
Organizational Affiliation
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
http://research.microsoft.com/en-us/default.aspx
Description
Related Info
URL
http://www.youtube.com/watch?v=PVgiEtDbsQM#t=15
Description
Related Info
Learn more about this trial
Kinect-based Upper Limb Rehabilitation System in Stroke Patients
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